Sensitivity Evaluation of Serological Tests for Covid-19

• Conditions: Covid19

• Registration Number: NCT04678024
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

The primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Status Verified: 2020-12
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-21
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24
• Primary Completion: 2021-08
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

All patients or individuals exposed to Sars-Cov2 Infection.

Exclusion Criteria

There are no criteria for excluding patients or individuals, if not the refusal to participate to project

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	Up to 22 weeks	Sensitivity and Specificity Evaluation in Diagnostic Sierological tests

Secondary Outcome Measures

Name	Time	Method
Specificity	Through study completion, an average of 1 year	Sensitivity and Specificity Evaluation in Diagnostic Sierological tests

Trial Locations

Locations (1)

Istituto Ortopedico Galeazzi; 🇮🇹 Milan, Italy